Medwave, Inc.: FDA clearances and approvals
Medwave, Inc. has 5 FDA 510(k) clearances (first 1995, latest 2006), across 1 product code in 1 review panel. Median 510(k) review time: 70 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Medwave, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061557 | FUSION | DXN | 2006-09-15 | 102 |
| K053185 | PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM | DXN | 2006-01-24 | 71 |
| K011152 | VASOTRAC APM205A | DXN | 2001-05-31 | 45 |
| K001898 | VASOTRAX | DXN | 2000-08-31 | 70 |
| K950249 | VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205 | DXN | 1995-02-01 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Medwave, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medwave, Inc. have?
Medwave, Inc. has 5 FDA 510(k) clearances (first 1995, latest 2006), across 1 product code in 1 review panel.
How long does FDA take to clear Medwave, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medwave, Inc.'s cleared 510(k)s is 70 days.
What devices does Medwave, Inc. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5).
Has Medwave, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medwave, Inc. Related entities may recall under other names.
Next steps
- See all 5 Medwave, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Medwave, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.